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Table 1 Study design, schedule for BT, PD, and edoxaban PK evaluations

From: Effects of concomitant use of prasugrel with edoxaban on bleeding time, pharmacodynamics, and pharmacokinetics of edoxaban in healthy elderly Japanese male subjects: a clinical pharmacology study

SubjectsHealthy elderly Japanese male subjects (Age: 65–80)
Study designOpen-label, parallel-group, repeated-dose
Sample size24 Subjects randomized into two groups
Group 1, n = 12
30 mg Edoxaban + 2.5 mg Prasugrel
Group 2, n = 12
30 mg Edoxaban + 3.75 mg Prasugrel
TreatmentsStage 1: all participants Day 1, 2, 3: 30 mg Edoxaban once daily
Stage 2: Day 4, 5, 6, 7, 8
Group 1: 30 mg Edoxaban + 2.5 mg Prasugrel once daily
Stage 2: Day 4, 5, 6, 7, 8
Group 2: 30 mg Edoxaban + 3.75 mg Prasugrel once daily
Schedule of procedures and blood sample collections
Bleeding time (BT)a& PD EvaluationbDay 0: Day of admission
Day 3: Three hours after administration of edoxaban
Day 8: Three hours after administration of edoxaban + prasugrel
Edoxaban PKDay 1: Pre-administration of study drug
Day 3: Pre-administration and 0.25, 0.5, 1, 2, 3, 4, 8, 12, 24 h after administration of edoxaban
Day 8: Pre-administration and 0.25, 0.5, 1, 2, 3, 4, 8, 12, 24 h after administration of edoxaban + prasugrel
  1. aIvy Method
  2. bPD indices: prothrombin time (PT), activated partial thromboplastin time (aPTT), prothrombin fragment 1 + 2 (F1 + 2), and P2Y12 reaction units (PRU)